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U.S. Department of Health and Human Services

Class 2 Device Recall DRI Cocaine Metabolite Assay, Multigent Cocaine Assay

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 Class 2 Recall
DRI Cocaine Metabolite Assay, Multigent Cocaine Assay
see related information
Date Posted September 23, 2013
Recall Status1 Terminated on December 02, 2013
Recall Number Z-2267-2013
Recall Event ID 65883
Premarket Notification
510(K) Number
K960187 
Product Classification Enzyme Immunoassay, Cocaine And Cocaine Metabolites - Product Code DIO
Product DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.
Code Information Part no. 0055, lot number 60053405, Exp 2/29/2016; Part No. 0056, lot number 60053396, Exp 2/29/2016; Part No. 10014593, lot number 60112588, Exp 2/29/2016; - not distributed Part number #l40-20, lot number 24215M500, Exp 8/13/14.
Recalling Firm/
Manufacturer
Microgenics Corp
46360 Fremont Blvd
Fremont, California 94538-6406
For Additional Information Contact Laurie Wong
510-979-5145
Manufacturer Reason
for Recall
Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Thermo Fisher Scientific sent an Urgent Medical Device Recall letters dated July 23, 2013, except Abbott labs who was mailed a letter on August 2, 2013. Abbott had previously been notified by telephone of the recall.The letter identified the product the problem and the action needed to be taken by the customer. Customers advised users on reagent stability issue with specific lots and the fact that it indicated a faster than expected degradation of the reagent. Microgenics asked that all use of the affected lots be stopped. Customers were informed that since each patient run is monitored with the controls at +/-25% of the cutoff, a possibility of reporting incorrect patient results is minimal to nonexistent. The use of appropriate controls addresses an risks of incorrect results. In addition to stopping use of the affected reagent, customers are asked to contact Thermo Fisher Scientific for replacement and to keep a copy of the recall letter for laboratory files. If the affected lots of reagent were forwarded to any other laboratories, they should be contacted immediately.. The enclosed acknowledgement form is to be completed and returned indicating that the letter was received, how much product, if any was on hand and destroyed. Questions and concerns may be addressed to Microgenics Technical Service at 1-800-232-3342 or 510-979-5417.
Quantity in Commerce 1473 units in distribution.
Distribution US Distribution including the states of DC, MA, NJ, TX. FL, CA, WA, NY, TX, CT, KY, LA, AR, TN, AL, GA, CT, VA, NC, KS, MD, OH and IL
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DIO and Original Applicant = DIAGNOSTIC REAGENTS, INC.
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